{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196484",
      "product_res_number": "Z-0228-2023",
      "event_date_initiated": "2022-09-30",
      "event_date_posted": "2022-11-11",
      "recall_status": "Open, Classified",
      "res_event_number": "91006",
      "product_code": "DXE",
      "k_numbers": [
        "K992368"
      ],
      "product_description": "TufTex Embolectomy Catheter, Model No. \n\nThis catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..",
      "code_info": "Lots XSL0097, XSL0098, and XSL0099",
      "firm_fei_number": "1220948",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "32 3rd Ave",
      "city": "Burlington",
      "state": "MA",
      "postal_code": "01803-4414",
      "additional_info_contact": "Laurie Churchill\n781-425-1714",
      "reason_for_recall": "Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.",
      "root_cause_description": "Process design",
      "action": "On September 30, 2022, the recalling firm notified affected customers via Urgent Field Safety Notice letters.\n\nUsers were instructed to immediately  identify, quarantine, and return the affected devices.",
      "product_quantity": "72 (OUS only)",
      "distribution_pattern": "No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.",
      "openfda": {
        "k_number": [
          "K893680",
          "K970657",
          "K883852",
          "K901627",
          "K011783",
          "K872485",
          "K770714",
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          "K901625",
          "K920823",
          "K022145",
          "K971314",
          "K992940",
          "K992933",
          "K973465",
          "K914880",
          "K982141",
          "K972572",
          "K780762",
          "K864330",
          "K992368",
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          "K864007",
          "K163031",
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          "K850015",
          "K961992",
          "K840198",
          "K961716",
          "K163353",
          "K240078",
          "K812640",
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          "K901502",
          "K100840",
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          "K894681",
          "K853625",
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          "K761031",
          "K897184",
          "K973477",
          "K233619",
          "K233819",
          "K801650",
          "K992934",
          "K832023",
          "K864062",
          "K241330",
          "K970762",
          "K820646",
          "K100842",
          "K920871",
          "K900311",
          "K020634",
          "K881455",
          "K910372",
          "K193379",
          "K972623",
          "K950586",
          "K233820",
          "K974335",
          "K902327",
          "K213771",
          "K790838",
          "K935405",
          "K002627",
          "K905139",
          "K892410",
          "K891021"
        ],
        "registration_number": [
          "",
          "3013666218",
          "8043983",
          "1820334",
          "2015691",
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          "9617465",
          "2522007",
          "3035111606"
        ],
        "fei_number": [
          "",
          "3013666218",
          "3035111606",
          "1820334",
          "2015691",
          "2024311",
          "3030714660",
          "1000393132",
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          "1000512168",
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          "3012050423",
          "3010041511",
          "3003737899",
          "3003769549",
          "2522007",
          "3005747797"
        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}